The goal of this randomized controlled trial is to evaluate the early bactericidal activity, early inflammatory response, and safety of omega-3 long chain polyunsaturated fatty acid (n-3 PUFA) supplementation in adult patients (aged 18- 45 years) with newly diagnosed, bacteriologically confirmed drug-sensitive pulmonary tuberculosis.
The main questions it aims to answers are:
* Does adjunct n-3 LCPUFA supplementation reduce the sputum culture time to positivity * Does it improve inflammatory markers and TB treatment outcomes compared to placebo Researchers will compare daily supplementation with \~2g n-3 LCPUFA (EPA and DHA ) to placebo (high linoleic sunflower oil) to determine effects on bactericidal activity, inflammation, and clinical outcomes.
Participants will:
* Be randomly assigned to receive either n-3 LCPUFA or Placebo daily for 8 weeks with the intensive phase of TB treatment * Attend clinical visit baseline, and follow up visit mostly weekly for 2 months and then monthly for 4 months of the continuous phase of TB treatment * Provide blood, sputum and urine samples for biomarkers and metabolomic analysis * Undergo assessments of iron status, body composition and muscle strength
adults aged 18-45 years
laboratory confirmed Pulmonary TB defined as a hard copy of a sputum result detected by WHO recommended assay or mycobacteria culture.
Women of childbearing potential with a negative pregnancy test on enrollment
All participant irrespective of HIV status who consent to have a HIV test during enrollment.
Comorbid condition with treatment of NSAIDS is indicated
Institutionalized or incarcerated individuals
Those on Multiple drug resistance treatment for more than 4 days within the past 6 months or within 1 month to prior to TB treatment initiation
Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn
North-West University, South Africa
Lead sponsor
Perinatal HIV Research Unit of the University of the Witswatersrand
Collaborator